UMIN-CTR Clinical Trial

Basic information
Public title	Comparison on the occurrence of bleeding related events in influenza outpatients by treatment status using health insurance claims database
Acronym	Comparison on the occurrence of bleeding related events in influenza outpatients by treatment status using health insurance claims database
Scientific Title	Comparison on the occurrence of bleeding related events in influenza outpatients by treatment status using health insurance claims database
Scientific Title:Acronym	Comparison on the occurrence of bleeding related events in influenza outpatients by treatment status using health insurance claims database
Region	Japan

Condition
Condition	Influenza virus infection
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the occurrence of bleeding related events in influenza outpatients by treatment status.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Occurrence of bleeding related events
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients whose first diagnosis date for influenza (Day 1) was within the enrollment period (1st Oct 2017 to 11th April 2019) 2) Patients who received some outpatient consultation (medical care or drug prescription) on Day 1. 3) Patients who were continuously registered in the database for at least 6 months before Day 1
Key exclusion criteria	1) Patients who have another influenza diagnosis in the last 20 days before Day 1. 2) Patients who received anti-influenza drugs in the last 20 days before Day 1. 3) Patients who withdrew from the database before Day 20. 4) Patients who were hospitalized on Day 1. 5) Patients who received several anti-influenza drugs on Day 1.
Target sample size	1300000

Research contact person
Name of lead principal investigator	1st name Hisashi Middle name Last name Urushihara
Organization	Keio University, Faculty of Pharmacy
Division name	Drug Development & Regulatory Science Faculty of Pharmacy
Zip code	105-8512
Address	1-5-30 Shibakoen, Minato-ku, Tokyo 105-8512, Japan
TEL	+81-3-5400-2649
Email	urushihara.hisashi@keio.jp

Public contact
Name of contact person	1st name Kanae Middle name Last name Hara
Organization	Shionogi & Co., Ltd.
Division name	Pharmacovigilance Department
Zip code	541-0045
Address	1-8, Doshomachi 3-Chome, Chuo-ku, Osaka 541-0045, Japan
TEL	+81-6-6209-6958
Homepage URL
Email	kanae.hara@shionogi.co.jp

Sponsor
Institute	Shionogi & Co., Ltd.
Institute
Department

Funding Source
Organization	Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Keio University Ethics Committee
Address	1-5-30 Shibakoen, Minato-ku, Tokyo 105-8512, Japan
Tel	+81-3-3434-6241
Email	skc-soumu@adst.keio.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 08 Month 26 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2020 Year 07 Month 13 Day
Date of IRB	2020 Year 07 Month 13 Day
Anticipated trial start date	2020 Year 07 Month 13 Day
Last follow-up date	2020 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational Study

Management information
Registered date	2020 Year 08 Month 26 Day
Last modified on	2022 Year 05 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047084